Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05313191

Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors

Led by The New York Proton Center · Updated on 2026-04-13

1800

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of different doses and schedules of Proton Therapy for patients with tumors that have returned or newly appeared after prior radiation treatment. Traditional photon radiation therapy exposes healthy tissues to radiation, limiting the dose that can be safely given. Proton therapy may better target tumors while sparing healthy tissue, potentially allowing for more effective treatment of recurrent tumors in patients who have previously received radiation to the same area. The study includes various patient groups with different tumor types, such as central nervous system, head and neck, breast, thoracic, gastrointestinal, genitourinary, and gynecological cancers. All participants receive Pencil Beam Scanning Proton Therapy, which is being compared to historical outcomes from traditional photon therapy. The study includes both prospective phase II trials and registry cohorts, with minimum intervals between radiation courses and specific criteria for each tumor group. Participants are monitored for treatment-related side effects and tumor control outcomes, with primary focus on adverse events of grade 3 or higher within one year after completing reirradiation. Secondary outcomes include survival rates, progression-free survival, and patient-reported outcomes using specific symptom assessment forms. Follow-up includes assessments at 90 days, one year, two years, and up to five years. Participants undergo clinical evaluations, imaging, and laboratory tests as needed throughout the study period.

CONDITIONS

Brief Title

Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patient provides study specific informed consent prior to study entry
  • Documented history and physical exam within 90 days prior to registration
  • ECOG performance status 0, 1, or 2 within 90 days prior to registration
Not Eligible

You will not qualify if you...

  • Non malignant systemic disease that would prevent study treatment or required follow up
  • Prior invasive non-study malignancy unless disease free for 3 or more years
  • History of active connective tissue disorder such as systemic lupus erythematosus, scleroderma, dermatomyositis, or xeroderma pigmentosum

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of proton therapy as per individual treatment plan

Participants receive Pencil Beam Scanning Proton Therapy for reirradiation of recurrent or new primary tumors in previously irradiated areas.

Multiple visits for radiation therapy sessions as scheduled

Follow-up

Duration - Up to 5 years

Participants are monitored for treatment-related adverse events and outcomes for up to 5 years after completion of reirradiation.

Regular follow-up visits as scheduled over 5 years

Trial Site Locations

Total: 1 location

1

The New York Proton Center

New York, New York, United States, 10035

Actively Recruiting

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Research Team

R

Ryan Holder, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

8

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